(43 days)
The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.
The Heelbo Blazer Sleeved Jacket is a jacket-style safety vest. The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is secured to a bed or wheelchair with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed. The jacket has Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release. The Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots. The Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Blazer Sleeved Jacket is made of durable machine washable materials and is color coded for easy size identification.
This document describes a medical device, the Heelbo Blazer Sleeved Jacket, which is a patient restraint. The provided text is a "Safety and Effectiveness Summary" for a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data often found for novel devices or AI/ML.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided document. The summary focuses on comparing the proposed device to a predicate device based on intended use, design, materials, manufacturing, and safety/effectiveness history.
Here's a breakdown of what can be extracted and why other questions cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics in the provided text. The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness. This is achieved by comparing intended use, technological characteristics, and safety profiles.
- Reported Device Performance: The document states: "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification."
- This implies the performance is considered identical to the predicate device. However, specific performance metrics (e.g., tensile strength, comfort scores, fall rates, etc.) are not quantified or reported.
Summary Table (based on inferred criteria for 510(k) and provided text):
| Acceptance Criteria (Inferred for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Device helps support and prevent slumping/sliding; limits movement to prevent falls. | Identical to predicate device. |
| Design: Jacket-style safety vest with sleeves, straps, loops, Velcro®, zipper, optional knotless system. | Identical to predicate device. |
| Materials: Poly/cotton blend or polyester mesh. | Identical to predicate device. |
| Manufacturing Process: Not specified, but implied to be identical to predicate. | Identical to predicate device. |
| Physical and Mechanical Specifications: Not specified, but implied to be identical to predicate. | Identical to predicate device. |
| Safety and Effectiveness: No adverse events, no reports/complaints of skin irritation; history of safe use of materials. | "Identical to predicate device." "Not aware of any reports or complaints of skin irritation." "History of safe use of their materials." |
| Biocompatibility: Materials have a history of safe use in clothing/garment industry. | "History of safe use of their materials in the clothing and garment industry." |
| Labeling Compliance: Revised to comply with FDA guidance. | Labeled to comply with FDA draft guidance (December 1995). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical study with a "test set" in the context of AI/ML or a traditional clinical trial. The basis for safety and effectiveness is largely a comparison to a predicate device and historical data on material safety, not a specific patient cohort tested with the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. Ground truth, in the context of device performance data, is not established as part of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or related adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This device is a physical restraint, not an AI/ML-powered diagnostic tool. MRMC studies are irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a physical restraint, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred Ground Truth: For a 510(k) of this nature, the "ground truth" for safety and effectiveness is essentially:
- Predicate Device Performance: The known performance and safety record of the existing Heelbo Blazer Sleeved Jacket (the predicate).
- Material Safety History: General industry knowledge and supplier statements regarding the safe use of the component materials (poly/cotton, polyester mesh) in clothing/garments.
- Absence of Adverse Events: The submitter's statement that they "are not aware of any reports or complaints of skin irritation associated with these materials."
8. The sample size for the training set
- Not applicable / Not provided. This device is not an AI/ML system, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set exists for this type of device.
In conclusion, this document is a regulatory submission demonstrating equivalence for a physical medical device. It does not contain the detailed study information typically associated with performance claims for diagnostic devices, particularly those involving AI/ML.
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.